510(k) · Cleared
ClearedUnipolar Optical Biopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Winter & Ibe GmbH · KGE Forceps, Biopsy, Electric
Cleared on Dec 24, 1998 as substantially equivalent to K790071 (Olympus Corp., 1979) after a 57-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.
- Decided
- Dec 24, 1998
- Review
- 57 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K790071 (1979). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K171916Single Use Hot Biopsy Forceps FD-231Olympus Medical Systems Corp. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790071 | Endoscope and Accessories | Olympus Corp. | 1979 | 6 |
| 0 (this device) | K983811 | Unipolar Optical Biopsy Forceps | Olympus Winter & Ibe GmbH | 1998 | — |
| +1 | K171916 | Single Use Hot Biopsy Forceps FD-231 | Olympus Medical Systems Corp. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGE device
- #1 K251807 Single Use Electrosurgical Hemostatic Forceps…score 11.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K790071 | Endoscope and AccessoriesSummary page 1…cation Name: Endoscopic Electrosurgical Unit and Accessories Classification: CFR 876.4300 Class 11 Predicate Devices: Olympus 05106 Rigid biopsy forceps with spoon jaw K790071 Olympus 05105 Rigid biopsy forceps, insulated K790071 Olympus 03109/A Biopsy forceps with sharp cutting jaws K790071 Olympus 0… | 1979 |
| * | — | Karl Storz Biopsy Forceps, through cutting, double action jaws, unknown for unipolar… Named without a submission number | |
| * | — | Richard Wolf Coagulating biopsy forceps by Tauber Type 8650.62 unknown Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171916 | Single Use Hot Biopsy Forceps FD-231 | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KGE devicesKGE Forceps, Biopsy, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGE
184in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGE
No recall names KGE since 2007.
Adverse event reports per year · KGE
10in 2025
MAUDE reports naming product code KGE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 15 |
| 2009 | 2 | — | 0 | 75 |
| 2010 | 1 | — | 0 | 29 |
| 2011 | 0 | — | 0 | 51 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 102 | 0 | 9 |
| 2017 | 2 | — | 0 | 26 |
| 2018 | 3 | 184 | 0 | 26 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 2 | — | 0 | 24 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OLYMPUS Unipolar Optical Biopsy Forceps has been designed for endoscopic biopsy and coagulation within the urinary tract.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983811: Unipolar Optical Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983811
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026